ISO/IEC 17025:2005 specifies the general requirements for competence, consistent and impartiality operation of laboratories. This international quality standard applies to all organizations performing laboratory activities, regardless of the number of personnel. Our previous two blogs regarding ISO 17025:2005 management requirements have already mentioned the required general management standards for your acknowledgment and now this final part will display the remaining management requirements for your review.
The remaining ISO 17025:2005 management requirements are as follows:
The objective of the following chapter is to reduce the likelihood of the occurrence of potential nonconformities.
- A procedure should be in place to identify potential sources nonconformities and define preventive actions to future preventing of these nonconformities.
- The effectiveness and results of the preventive action should be monitored and evaluated.
Control of Records
The process to uniquely identify, avail earliest when needed, and protected against unauthorized access for viewing or changing is described here.
- A proper process should be in place to identify, collect, index, storage, retrieve, and disposal of laboratory records.
- Security, confidentiality, quality, and integrity of records should be maintained properly during the storage of records.
- Original observations along with processing parameters that will allow tracking final results back to the original observations should be retained properly.
- There should be a procedure to protect and backup electronic records and prevent unauthorized access to them.
- Wrong records can be corrected. The original records should be crossed out, but still visible.
- The original records should not be overwritten by the system and corrections made should be recorded together with the original records.
The section of internal audits helps in the continual improvement of the quality system. Let’s know the key points of the internal audit chapter for ISO 17025:2005.
- There should be a procedure and a schedule for internal audits. It can either cover the whole laboratory and all the elements of the quality system at one specific period or can be divided into several subsections.
- Each element of the quality system and every section of the laboratory should be audited yearly.
- The whole audit program should be properly managed by quality managers.
- A report to customers should be provided related to audit findings for calibration results and the quality of the test.
- The effectiveness of audit plans should be monitored.
The continued suitability and effectiveness of the quality system, policies, and calibration and testing system is described in this chapter.
- A scheduled procedure for periodic management reviews.
- The management review should include a discussion about the outcomes of recent corrective and preventive actions, internal audits and external assessments, results of proficiency testing, and other recommendations for improvement.
- The follow-up activities should be decided by the management, and later monitored for the effectiveness.
So, this is the complete set of management requirements for ISO 17025:2005.
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